About Us

Modicus Prime is improving the quality of pharmaceutical drug manufacturing and saving patient lives by leveraging the power of compliant AI and advanced analytics. Modicus Prime is a Johnson & Johnson JLABS company and venture-backed by Austin-based Silverton Partners along with strategic partnerships at several large corporations including Takeda Pharmaceuticals, Oak Ridge National Laboratory (DOE), eLabNext (Eppendorf), Dotmatics, and PlugandPlay. Modicus Prime has been featured in the Wall Street Journal and BioProcess International, and the CEO is co-author of the pharmaceutical industry's ISPE AI Guide (2025).

We are now seeking an IT Quality and Compliance Lead to join our company. If you are eager to impact the AI/ML integration in the pharmaceutical industry and enjoy rapidly scaling products and teams, consider applying to join our company.

Position Overview and Key Responsibilities

Responsible for establishing and maintaining quality and compliance standards across technology services organizations (Information Technology, Software Development) and ensuring such standards comply with regulatory requirements and best practice. This position is responsible for working alongside leadership to achieve corporate and departmental compliance goals as well as ensuring the organization remains compliant with the Quality Management System and technology processes.

Key Qualifications

• Engage in the continued development, maintenance, and enforcement of the Quality Management System.
• Manage/lead efforts with regard to the development and maintenance of quality goals, objectives, and process improvements.
• Establish and enforce quality department standards.
• Coach and train personnel on quality department standards and best practices.
• Author/revise internal documents (e.g.Policies, SOPs, System Impact Assessments, Validation Documentation, Vendor Assessments, Periodic Reviews, Management Review etc).
• Ensure such standards are in conformity with applicable regulatory agency regulations and guidance.
• Oversee/manage/execute the implementation, development, and change management of systems/processes to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, ISPE GAMP 5, AI Guidances
• Manage/execute the integration, implementation, and/or development, of new businesses and/or systems.
• Serve as the primary technology quality liaison for the integration of new systems.
• Serve as the subject matter expert with respect to the harmonization of processes and procedures.
• Manage/lead the investigation of Corrective Actions Preventative Actions (CAPA), and deviations
• Ensure proper investigation of such events is performed, and documentation maintained
• Manage/lead internal audits to ensure internal standards and staff performance are in compliance with applicable process, regulatory agency regulation and guidance
• Manage/lead the conduct of internal audits/periodic review of company policies and procedures
• Manage/lead the conduct of internal audits/periodic review of systems
• Identify compliance gaps and provide support and suggestions for remediation. Report status of the quality levels of staff, systems and production activities to the VP of GxP Quality and Compliance
• Assist in the manual testing of software products and provide feedback via Jira tickets
• Assist in test case creation/review/execution as needed
• Maintain the compliance schedule of external vendor qualification to ensure that vendors remain in compliance with applicable processes.
• Assist with external audits and inspections including communication with client/agency, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.
• Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.
• Provide training and guidance to staff regarding compliance and interpretation of regulations.
• Other duties as assigned as needed. These may, on occasion, be unrelated to the position described here

Basic Qualifications

Bachelor’s degree in medicine, science, technology or equivalent combination of education and relevant professional experience.

Required Experience

• Minimum of three (3) years experience in a quality/regulatory compliance position, with a proven track record of success in leading/managing quality assurance projects/assignments, audits, and resources as well as monitoring and tracking compliance standards.
• Thorough knowledge of current regulatory guidelines as they apply to computerized systems, AI sub-systems, and AI-enabled systems
• Demonstrated knowledge of 21 CFR Part 11/ Annex 11 requirements and Computerized System Validation processes including SDLC.
• Experience in leading Computerized System Validation efforts of systems used in GxP settings.
• Strong organizational and planning skills.
• Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with staff, clients, and regulatory agencies as needed.
• Highly developed problem solving skills and the ability to resolve difficult conflicts.
• Ability to multitask and to work efficiently and independently.

What Success Looks Like

• A Quality Management System that is consistently applied across IT and software development and supports compliant, efficient delivery rather than slowing it down
• Systems, processes, and AI-enabled solutions that are audit-ready and demonstrably compliant with applicable regulations, including GxP, 21 CFR Part 11, and Annex 11
• Clear, practical quality standards that teams understand and follow, resulting in fewer deviations, well-rooted CAPAs, and sustained process improvements
• Smooth integration of new systems, vendors, and business activities with harmonized processes and well-controlled change management
• Leadership confidence in the organization’s technology compliance posture, supported by accurate reporting, timely risk identification, and effective remediation

This role is U.S.-based, and visa sponsorship cannot be accommodated at this time.

Additional Information

1. Location: Austin preferred
2. Job Type: Full-time
3. Pay (with equity): Salary/equity ratio dependent on candidate preferences, skills and/or qualifications

What We Offer

• Enjoy the benefits of a flexible work schedule within a remote working environment, while also having the opportunity to connect with your colleagues through regular in-person meetings in Austin, including team luncheons.
• The chance to lead groundbreaking AI initiatives that are transforming the pharmaceutical industry.
• A supportive and collaborative team culture, with ample opportunities for professional growth and development, including conference speaking opportunities.
• Comprehensive medical, dental, and vision coverage, along with a 401(k) retirement plan.

Equal Opportunity Employer Statement

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

To Apply

Please submit your CV and any relevant materials to info@modicusprime.com. We look forward to hearing from you and exploring how your ambitions and expertise can help shape the future of Modicus Prime and the pharmaceutical industry at large.